RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD

Prosthesis, Hip, Femoral, Resurfacing

BIOMET, INC.

The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Recap Ha Press-fit Femoral Resurfacing Head.

Pre-market Notification Details

Device IDK071053
510k NumberK071053
Device Name:RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD
ClassificationProsthesis, Hip, Femoral, Resurfacing
Applicant BIOMET, INC. P.O. BOX 587 Warsaw,  IN  46581 -0587
ContactBecky Earl
CorrespondentBecky Earl
BIOMET, INC. P.O. BOX 587 Warsaw,  IN  46581 -0587
Product CodeKXA  
CFR Regulation Number888.3400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-04-13
Decision Date2007-06-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304684645 K071053 000
00880304684447 K071053 000
00880304684461 K071053 000
00880304684485 K071053 000
00880304684508 K071053 000
00880304684522 K071053 000
00880304684546 K071053 000
00880304684560 K071053 000
00880304684584 K071053 000
00880304684607 K071053 000
00880304684621 K071053 000
00880304684423 K071053 000

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